Doxycycline for Lateral Epicondylalgia - RCT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Kaunas University of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital, Linkoeping
Information provided by:
Kaunas University of Medicine
ClinicalTrials.gov Identifier:
NCT00631501
First received: February 27, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

Matrix metalloproteinases are involved in the pathogenesis of tendinopathy. Doxycycline, a widely available pharmaceutical agent mostly used for its antibiotic properties, also functions as an inhibitor of MMPs.

This study aims to investigate the effect of doxycycline treatment on lateral epicondylalgia (tennis elbow). During three weeks, patients receive doxycycline tablets 100 mg twice daily, or placebo. Main outcome variable is pain (VAS) at three weeks.

Serum and/or plasma levels of matrix metalloproteinases and tissue inhibitors of metalloproteinases are measured.


Condition Intervention
Lateral Epicondylalgia (Tennis Elbow)
Drug: Placebo
Drug: Doxycycline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kaunas University of Medicine:

Primary Outcome Measures:
  • Pain (VAS) [ Designated as safety issue: No ]

Estimated Enrollment: 34
Arms Assigned Interventions
Placebo Comparator: 2 Drug: Placebo
Experimental: Doxycycline
100 mg twice daily
Drug: Doxycycline

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65
  • Pain at the lateral side of the elbow ≥8 weeks
  • Local tenderness on palpation of the lateral epicondyle
  • Pain on resisted extension of the wrist

Exclusion Criteria:

  • Rheumatic disorder
  • History of fibromyalgia or generalised pain
  • Elbow surgery (on the painful side)
  • Active infection
  • Glucocorticoid treatment during the duration of symtoms of epicondylalgia
  • NSAID use within 1 w before presentation and during the study
  • Pregnancy
  • Taking drug that might interact with doxycycline
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631501

Contacts
Contact: Alfredas Smailys, MD, PhD +370 37 327201 smailys@takas.lt

Locations
Lithuania
Dept of Orthopaedics, Kaunas Medical University Recruiting
Kaunas, Lithuania
Contact: Alfredas Smailys       smailys@takas.lt   
Sponsors and Collaborators
Kaunas University of Medicine
University Hospital, Linkoeping
  More Information

No publications provided

Responsible Party: Per Aspenberg, Dept of Orthopaedics, University Hospital Linkoeping
ClinicalTrials.gov Identifier: NCT00631501     History of Changes
Other Study ID Numbers: BE-2-47
Study First Received: February 27, 2008
Last Updated: February 27, 2008
Health Authority: Lithuania: Kaunas University of Medicine

Keywords provided by Kaunas University of Medicine:
tendinopathy
tennis elbow
lateral epicondylitis
lateral epicondylalgia
MMP-inhibitor

Additional relevant MeSH terms:
Arm Injuries
Tennis Elbow
Musculoskeletal Diseases
Wounds and Injuries
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 28, 2014